FDA beefs up warnings on J&J, AZ SGLT2 meds, leaving Lilly and BI the happy exception


The FDA is strengthening its kidney injury warning on Johnson & Johnson’s Invokana and AstraZeneca’s Farxiga--which may mean a boost for Eli Lilly and Boehringer Ingelheim’s Jardiance, the only other med in the SGLT2 class of diabetes drugs.

Regulators have revised the warnings in the products’ labels to include information about acute kidney injury, they said Tuesday. They’ve also added recommendations to minimize risk; docs should consider factors that could predispose patients to acute kidney injury--such as decreased blood volume and congestive heart failure--before starting on either med, they said. Healthcare professionals should also take a close look at patients’ kidney function before they start treatment and continue to monitor them after that--immediately discontinuing use of the therapies if acute kidney injury crops up.

With the beefed up warning on its rivals, Jardiance remains the odd drug out--and that’s a position it’s happy to be in. The third-to-market med has been working to break away from the pack since hitting the scene in 2014, with both of its makers counting on it to provide serious sales growth going forward.

Lately, though, they’ve had no shortage of encouraging news on that front. Last fall, Jardiance became the first diabetes drug to show it could slash the combined rate of heart attack, stroke and cardiovascular death in high-risk patients. And while it no longer holds the distinction of being the only one to do so, its SGLT2 brethren still can’t make the same claims; J&J and AZ will wrap their respective outcomes trials in 2017 and 2019, respectively.

The label tweaks also come on the heels of some positive kidney disease outcomes data for Jardiance, presented Tuesday at the American Diabetes Association’s annual meeting. Study results showed that the product cut the risk for new-onset or worsening kidney disease by 39% compared with placebo when added to standard-of-care treatment for adults with Type 2 diabetes and established cardiovascular disease.

- read the FDA alert

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